InterCollagen® Guide

K223912 · Sigmagraft, Inc. · NPL · Aug 17, 2023 · Dental

Device Facts

• Record ID: K223912
• Device Name: InterCollagen® Guide
• Applicant: Sigmagraft, Inc.
• Product Code: NPL · Dental
• Decision Date: Aug 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration. - · in the context of a treatment of fenestration defects - · in case of dehiscence defects - · after apicoectomy and resection of retained teeth - · in extraction sockets after tooth extractions - · in case of immediate or delayed augmentation around implants in extraction sockets

Device Story

InterCollagen® Guide is a resorbable porcine pericardium-derived collagen membrane used in dental/periodontal surgery. It acts as a cell-occlusive barrier to prevent non-osteogenic cell infiltration into bone defects, facilitating bone-forming cell ingrowth. The device is trimmed to size and applied by a clinician during surgical procedures; it conforms to the site upon hydration. It is remodeled and incorporated by host tissue, resorbing within 15 weeks. The membrane provides a stable environment for bone regeneration, potentially improving clinical outcomes in defect repair and implant site preparation.

Clinical Evidence

No clinical data. Evidence consists of bench testing (biocompatibility per ISO 10993, pyrogenicity, shelf-life/packaging) and a canine two-wall intrabony defect model comparing the subject device to the predicate. Animal study endpoints (pathology, histology, histomorphology, micro-CT) at 2, 6, and 13 weeks showed performance substantially equivalent to the predicate.

Technological Characteristics

Resorbable collagen membrane (Type I and III) derived from porcine pericardium. Dimensions: 12x25mm to 30x40mm. Sterilized via gamma irradiation (SAL 10^-6). Biocompatible, cell-occlusive, implantable. Packaging: double blister pack. Complies with ISO 10993, ISO 22442, ISO 11137, ISO 11607, and ASTM D4169.

Indications for Use

Indicated for patients requiring guided bone or tissue regeneration in dental/periodontal surgical procedures, including fenestration defects, dehiscence defects, post-apicoectomy/resection, extraction sockets, and implant site augmentation.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Straumann Jason Membrane (K173562)

Submission Summary (Full Text)

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08/17/23

SigmaGraft Inc. Elcin Chang General Manager 575 Sally Place Fullerton, California 92831

## Re: K223912

Trade/Device Name: InterCollagen® Guide Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: July 26, 2023 Received: July 26, 2023

# Dear Elcin Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223912

Device Name InterCollagen® Guide

Indications for Use (Describe)

InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.

- · in the context of a treatment of fenestration defects
- · in case of dehiscence defects
- · after apicoectomy and resection of retained teeth
- · in extraction sockets after tooth extractions
- · in case of immediate or delayed augmentation around implants in extraction sockets

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for SigmaGraft Biomaterials. The logo features a stylized blue letter "E" with the word "GRAFT" above the bottom portion of the "E" and the word "Biomaterials" below the bottom portion of the "E". To the right of the logo is the word "SigmaGraft" in a large, bold, blue font.

Date Prepared:

#### FDA 510(k) Summary

August 16, 2023

**Submitter's Contact Information**

| Submitter: | SigmaGraft, Inc. 575 Sally Place Fullerton, CA 92831, USA |
|-----------------|-----------------------------------------------------------|
| Contact Person: | Elcin Chang |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Prepared By: | Elcin Chang, General Manager |

Email:

#### Name of the Device

- Trade Names: Common Name: Classification Name: Regulation Number: Device Classification: Product Code(s): Classification Panel:
#### Predicate Device

Primary Predicate: Common Name: Classification Name: Regulation Number: Device Classification: Product Code(s): Classification Panel:

InterCollagen® Guide Bone Grafting Material Barrier, Animal Source, Intraoral នូវ72.3930 II NPL Dental

[e-mail]

Straumann Jason Membrane (K173562) Bone Grafting Material Barrier, Animal Source, Intraoral ន្ល872.3930 II NPL Dental

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Image /page/4/Picture/0 description: The image shows the logo for SigmaGraft Biomaterials. The logo features the text "SigmaGraft" in a bold, sans-serif font, with the word "Sigma" in a slightly larger font size than "Graft". To the left of the text is a stylized graphic element, possibly representing the Greek letter sigma, along with the text "Graft Biomaterials".

# Device Description

InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.

## Sizes

| Type | Size (mm) | Product code |
|------------------------------|-----------|--------------|
| Resorbable Collagen Membrane | 12 x 25 | ICG1225 |
| | 15 x 20 | ICG1520 |
| | 20 x 30 | ICG2030 |
| | 25 x 25 | ICG2525 |
| | 30 x 40 | ICG3040 |

InterCollagen® Guide is provided in five different sizes:

# Indications for Use

InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) can be used in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier for:

- . in the context of a treatment of fenestration defects
- in case of dehiscence defects
- after apicoectomy and resection of retained teeth
- in extraction sockets after tooth extractions
- in case of immediate or delayed augmentation around implants in extraction sockets ●

# Summary/Comparison of Technical Characteristics

The subject device has substantially equivalent technological characteristics to the marketed predicate device. A comparison of the relevant technological characteristics between the subject and primary predicate device is provided in the table that follows.

# Biocompatibility Testing

A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device. Testing was determined in accordance with ISO 10993-1 and FDA Guidance on

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Use of International Standard ISO 10993-1 for the biological evaluation of medical devices within a risk management process.

The biocompatibility testing performed is summarized in the table below.

| Test | Standards | Result |
|---------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Mouse Lymphoma forward mutation<br>assay | ISO 10993-3,<br>OECD 476, OECD<br>490 | Non-mutagenic |
| Genotoxicity (Ames: Bacterial<br>Reverse Mutation) Test | ISO 10993-3 | Non-mutagenic |
| Kligman Maximization Sensitization<br>Test | ISO 10993-10 | Non-sensitizer |
| Intracutaneous irritation test | ISO 10993-10 | Non-irritant |
| Cytotoxicity L929 Neutral Red<br>uptake test | ISO 10993-5 | Non-cytotoxic |
| Acute Systemic Toxicity Test | ISO 10993-11 | Non-toxic |
| 90 day Subchronic Toxicity Test | ISO 10993-11 | Non-toxic |
| Pyrogenicity (material mediated) | ISO 10993-11 | Non-pyrogenic |
| Local effects after Implantation Test | ISO 10993-6 | Minimum tissue reaction at 2, 11,<br>and 15 weeks of implantation and<br>no adverse tissue reaction to the<br>host |

#### Animal Testing

The performance of the device in a canine two-wall intrabony defect model was compared to the performance of the predicate device, Jason membrane. The objective of this study was to evaluate the in vivo performance, local effects following implantation, and systemic toxicity of the test article, InterCollagen® Guide, in comparison to a predicate and empty control.

End points for pathology, histology, histomorphology and micro-CT were taken after 2, 6, and 13 weeks. The subject device performed in a manner substantially equivalent to the cleared predicate device.

#### Animal Tissue Management

Animal tissues are managed in accordance with the following standards and guidance documents:

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Image /page/6/Picture/0 description: The image shows the logo for SigmaGraft Biomaterials. The logo consists of the word "SigmaGraft" in a bold, dark blue font. To the left of the word is a stylized symbol that looks like a capital letter "E" with the letters "G", "R", "A", "F", and "T" stacked vertically to the left of the "E". Below the symbol is the word "Biomaterials" in a smaller font.

- ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1: Analysis and Risk Management
- ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of ● Medical Devices - Part 2: Controls on Sourcing, Collection, and Handling
- ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of ● Medical Devices – Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents
- Medical Devices Containing Materials Derived from Animal Sources (Except for In ● Vitro Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff, CDRH, FDA, March 15, 2019
- FDA Guidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products ● Derived from Cell Lines of Human or Animal Origin, CDER, CBER, September 1998

## Sterilization

Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of health care products – Radiation Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2 Sterilization of health care products – Radiation Part 2 Establishing the sterilization dose, and ISO 11737 Sterilization of Medical Devices – Microbiological Method – Determination of the Population of Microorganisms on Products.

# Pyrogenicity

This device is non-pyrogenic. Each batch of product manufactured is tested for endotoxin per the Limulus Amebocyte Lysate (LAL) endotoxin test, USP <85> and USP <161>, as finished product release test.

# Shelf Life and Stability

Product and packaging stability was determined using real-time aging data. Performance testing of packaging system was tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. Selection, qualification, and validation of packaging were conducted in accordance with ISO 11607 Packaging for Terminally Sterilized Medical Devices – Requirements for Materials, Sterile Barrier Systems, and Packaging Systems.

#### Viral Inactivation

Viral inactivation studies were performed in accordance with ISO 22442-3 to ensure the viral safety of the product.

# Clinical Studies

Clinical performance data was not required to determine substantial equivalence.

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# Conclusion

Chemical, physical, and biocompatibility tests as well as pre-clinical data show that the subject device is substantially equivalent to the predicate device. Comparison with the predicate device shows that the device has similar specifications and performance. Therefore, the conclusions drawn from the nonclinical and preclinical tests demonstrate that the device is substantially equivalent to its predicate device.

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| Feature | InterCollagen® Guide<br>(K223912) | Straumann Jason Membrane<br>(K173562) | Equivalence Discussion |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test article | Predicate device | |
| Indications<br>for Use | InterCollagen® Guide alone or in<br>combination with suitable<br>augmentation materials (like<br>autogenous bone, allogeneic,<br>xenogeneic or alloplastic bone<br>replacement materials) can be<br>used in guided bone regeneration<br>(GBR) and guided tissue<br>regeneration (GTR) procedures as<br>a biodegradable barrier for:<br>in the context of a treatment<br>of fenestration defects in case of dehiscence defects<br>after apicoectomy and<br>resection of retained teeth in extraction sockets after<br>tooth extractions in case of immediate or<br>delayed augmentation around<br>implants in extraction sockets | Jason membrane alone or in<br>combination with suitable<br>augmentation materials (like<br>autogenous bone, allogeneic,<br>xenogeneic or alloplastic bone<br>replacement materials) is indicated<br>for immediate or delayed guided<br>tissue and bone regeneration.<br>In case of surgical bone defects<br>and bone wall defects In the context of sinus floor<br>augmentation and support of the<br>Schneiderian membrane In the context of Maxillary ridge<br>augmentation In the context of Maxillary ridge<br>reconstruction for prosthetic In the context of Treatment<br>Fenestration defects In case of Periodontal bone<br>defects (1-3 wall defects) and<br>furcation defects (class I and II) In case of Dehiscence defects after<br>apicectomy, cystectomy, resection<br>of retained teeth and resection of<br>other bone lesions | Equivalent<br>Both devices are indicated for<br>immediate or delayed guided<br>tissue and bone regeneration.<br>The indications for the subject<br>device are a subset of the<br>indications for the predicate<br>device. |
| | | | |
| | | In extraction sockets after tooth extractions In case of immediate or delayed augmentation around implants in extraction sockets | |
| Mode of Action | InterCollagen® Guide is a bio-resorbable barrier which eventually is remodeled and/or incorporated by the host tissue. | Jason Membrane is a bio-resorbable barrier which eventually is remodeled and/or incorporated by the host tissue. | Equivalent<br>Both devices are resorbable and function as a barrier to provide adequate new bone formation without soft tissue infiltration. |
| Operating Principle | Cell-occlusive<br>Implantable<br>Resorbable<br>Biocompatible | Cell-occlusive<br>Implantable<br>Resorbable<br>Biocompatible | Equivalent<br>Both devices function as a barrier to provide adequate new bone formation without soft tissue infiltration. They are both implantable, resorbable, and biocompatible. |
| Material origin | Porcine pericardium | Porcine pericardium | Equivalent<br>Both devices use a native collagen membrane obtained from porcine pericardium. |
| Collagen Type | Collagen Type I and Type III | Collagen Type I | Equivalent<br>Both devices have mainly Collagen Type I. |
| Form | Membrane | Membrane | Equivalent |
| | | | They act as a barrier against the infiltration of cells not involved in bone formation. |
| Color | White to off white | White to off white | Equivalent<br>Both devices have color that is white to off white. |
| Sizes | 12 x 25 mm<br>15 x 20 mm<br>20 x 30 mm<br>25 x 25 mm<br>30 x 40 mm | 15 x 20 mm<br>20 x 30 mm<br>30 x 40 mm | Equivalent<br>Both devices are provided in clinically relevant sizes for intra-oral surgical procedures. |
| Resorption<br>Time | Substantially resorbed by 15 weeks | Substantially resorbed by 12 weeks | Equivalent<br>The longer endurance of the desired barrier properties provides adequate new bone formation without soft tissue infiltration. |
| Sterilization<br>Method | Irradiation | Ethylene Oxide | Equivalent<br>Both the subject and predicate device achieve a Sterility Assurance Level of 10-6. |
| Single<br>Use/Reuse | Single use only | Single use only | Equivalent<br>Both devices are single use only. |
| Packaging | Double blister pack | Double pouch pack | Equivalent<br>Both devices facilitate aseptic delivery of the sterile device into the sterile surgical field |

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